Document Controller
3 weeks ago
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OverviewOn behalf of a client in the greater Cork area, PM Group are looking to hire a seasoned Document Controller to provide documentation support to their vaccines production team.
Responsibilities- Creating, editing, and formatting of SOPs, Work Instructions, and other documents on Client's EDMS from material supplied by the Vaccine IPT SMEs.
- Liaison with key stakeholders e.g., Quality, Change Control, SMEs etc. to ensure compliance, correctness, content, and delivery.
- Lead the tracking and maintaining of the project document delivery schedules for the team (using Excel).
- Engage with Change Control and the wider project team to ensure documents are prepared and updated in time for different stages of C&Q execution and production.
- Provide knowledge and experience in Quality Documentation Systems to the site.
- Responsible for the use of the Site Documentation System including Issuance, reconciliation, storage, archiving, and retrieval of cGMP documentation to support the manufacture & testing of our products.
- Responsible for maintaining the Site Master file for current effective cGMP documents on site at Brinny.
- Use knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement, and execute tasks.
- Provide compliance contribution to project teams and lead small projects.
- Make decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
- Partake in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
- Ensure compliance with site EHS policy, cGMP, and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations.
- Ensure the highest Quality, Compliance, and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
In order to excel in this role, you will need to have:
- 5 years' experience as a documentation specialist or equivalent in a pharmaceutical or a highly regulated environment.
- Experience in maintaining and updating excel schedules and trackers for small projects.
- Advanced PC skills such as Excel, Word, PowerPoint.
- Stakeholder management of multi-decision makers, colleagues, peers, and cross-functional teams.
- Knowledge and experience of GMP and GDP in a pharmaceutical environment.
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g., Manufacturing, Quality, Engineering, Tech Services etc).
- Qualification in a biological science subject.
- Evidence of Continuous Personal Development.
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